GlobalData on MSN

GSK’s Blenrep gains FDA approval for myeloma treatment

The approval is based on data from a Phase III trial evaluating patients who had received two or more previous treatments.

FDA clears return of GSK’s once-withdrawn multiple myeloma drug

The new approval completes a surprise turnaround for Blenrep, which was initially cleared in 2020 but pulled from the market ...
Fierce Pharma

GSK's once-withdrawn Blenrep gets 2nd wind in US with FDA nod to treat certain myeloma patients

Three years after its global market withdrawal and months after a negative advisory committee vote, GSK can officially call it a comeback for its multiple myeloma drug Blenrep in the U.S., albeit w | ...
Fierce Biotech

ESMO: GSK says 'stay tuned' for more ADC data after partner Hansoh posts 49% response rate

GSK may be happy with the latest readouts from two Hansoh-partnered antibody-drug conjugates, but the Big Pharma’s oncology R ...
pharmaphorum

GSK's Blenrep's back in US, but with a narrower label

Against the odds, GSK has secured FDA approval for its multiple myeloma therapy Blenrep, three years after it was removed ...
TipRanks on MSN

GSK Expands Share Buyback Program with Latest Purchase

GSK has announced the purchase of 248,000 of its own ordinary shares as part of its ongoing buyback program, executed through BNP Paribas SA. This move is part of a broader strategy initiated on ...
Fierce Biotech

GSK unveils positive pivotal data for Spero's once-rejected oral antibiotic

Under the terms of a deal that rescued the once-rejected tebipenem HBr, GSK will file for approval of the oral antibiotic. Back in 2022, after the FDA requested another phase 3 trial and denied ...